Patient Information (PAAB Code Section 6) Speaker: Malika Ladha, Reviewer, PAAB
Agenda The do s and don ts of patient materials. You ll identify a thought process for the patient audience to arrive at a compliant patient app. Relevant PAAB Code sections: PAAB 6
Consumer Content vs. Patient Info DTC General public Health Canada Guidelines PAAB Opinion Patient Patient taking the drug PAAB Code s6 PAAB Review 3
Purpose of patient material Educational (see PAAB Code s6) Instructions on how to take medication and what to expect Consistent with Part III of Product Monograph Non-promotional context
Thought Process Sequence Is the piece only about the specific product which was prescribed?
Question? Arbace HCT is a tablet containing both arbsartan and the diuretic hydrochlorothiazide. Can we create a patient counselling tool which is branded for both Arbace and Arbace HCT? Yes No
Should be about the product and only the product the patient has been prescribed
Thought Process Sequence Is the piece only about the specific product which was prescribed? Is the drug content consistent with Part III of the Product Monograph? AND Is the disease content on label and supported by standard setting organizations or authoritative sources?
Standard Setting Organizations What they are: Group generally considered to be a credible source for patient information Package complex medical information in a manner which is easy for patients to understand What they are not: A person A commercial website Controlled by pharma
Standard Setting Organizations Patient groups (e.g., the Asthma Society of Canada) Medical institutions (e.g., a hospital) Health care professional organizations (e.g., Canadian Nurses Association) Consensus groups (e.g., Diabetes Canada)
HurtAway is used to relieve joint pain and swelling in osteoarthritis - Product Monograph (Part III) Inflammation can eventually lead to structural changes in joints Osteoarthritis is associated with swelling and joint pain Pain associated with osteoarthritis can affect your ability to exercise and your quality of life Is your osteoarthritis causing you joint pain? Participating in yoga can help keep your joints moving Case study: HurtAway
Disease content must be on label and supported by standard setting organizations or authoritative sources
Thought Process Sequence Is the piece only about the specific product which was prescribed? Is the drug content consistent with Part III of the Product Monograph? AND Is the disease content on label and supported by standard setting organizations or authoritative sources? Is the piece non-promotional?
Which of the following could appear in an Arbace patient piece? The copy Demonstrated lower cough incidence than Altace. Tagline Powerful antihypertensive The copy Arbace offers convenient administration. It can be taken with or without food. The copy Arbace may be taken with or without food. It should be taken consistently with respect to food intake, at the same time each day.
Patient information should be non-promotional X - Promotional efficacy claim X - Taglines repetition of a message
Thought Process Sequence Is the piece only about the specific product which was prescribed? Is the drug content consistent with Part III of the Product Monograph? AND Is the disease content on label and supported by standard setting organizations or authoritative sources? Is the piece non-promotional? Is risk information from Part III of the Product Monograph required?
Patient Support Program Promote company s services Drug specific claims Company X is proud to cover up to the difference between brand and generic price Price of Drug X has been reduced
Summary: Thought Process Sequence Is the piece only about the specific product which was prescribed? Is the drug content consistent with Part III of the Product Monograph? AND Is the disease content on label and supported by standard setting organizations or authoritative sources? Is the piece non-promotional? Is risk information from Part III of the Product Monograph required?